Clinical trials: Transcatheter Aortic Valve Implantation
Aortic Valve Stenosis
Non-Contrast Magnetic Resonance Angiography Assessment of Patients Referred for Transcatheter Aortic Valve Implantation
The overall objective of this proposal is to examine the feasibility and accuracy of non-contrast magnetic resonance angiography (MRA) to comprehensively evaluate individuals referred for transcatheter aortic valve implantation…
- Trial name
- NCT02007967
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Michigan
Aortic Stenosis
Impact of Beta-blocker on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement (B-TAVR)
This is a multi-centric, open-label, randomized trial to evaluate the safety and efficacy of temporary discontinuation of beta-blocker treatment in patients undergoing transcatheter aortic valve replacement.
- Trial name
- NCT06472934
- Testing
- Transcatheter aortic valve replacement in the absence of B-blocker treatment, Transcatheter aortic valve replacement
- Where
- 11 sites in Austria, Germany and 1 more
- Volunteers
- 498 people
- Sponsor
- University Hospital, Basel, Switzerland
Aortic Stenosis
Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement
To prove the non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.
- Trial name
- TAVR-CMR (NCT03831087)
- Testing
- TAVR-CMR, TAVR-CT
- Where
- Austria
- Volunteers
- 267 people
- Sponsor
- Medical University Innsbruck
Aortic Stenosis, Mitral Regurgitation
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.
To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve…
- Trial name
- MITAVI (NCT04009434)
- Testing
- Mitral Valve Clipping, TAVI
- Where
- Germany
- Volunteers
- 1,162 people
- Sponsor
- Technische Universität Dresden
Cerebral Embolicprotection Device, TAVR
Cerebral Embolic Protection Device During TAVR
To evaluate the safety and effectiveness of the Cerebral Protection System (model CEP016F, Shanghai Shenqi Medical Technology Co., Ltd.) for capturing and removing thrombotic and tissue debris during transcatheter aortic valve…
- Trial name
- NCT07627984
- Testing
- Cerebral embolic protection device
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Aortic Valve Stenosis
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI).
- Trial name
- CHOICE-CLOSURE (NCT04459208)
- Testing
- Manta, ProGlide
- Where
- Germany
- Volunteers
- 516 people
- Sponsor
- Helios Health Institute GmbH
Aortic Stenosis
Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA
This clinical trial, a prospective, randomized, multicenter study, assigns patients to either videodensitometry-guided TAVI or conventional TTE/TEE-guided TAVI (stand of care), with the primary endpoint being regurgitation…
- Trial name
- NCT06891079
- Testing
- Videodensitometric guided, Stand of care guided
- Where
- 2 sites in China
- Volunteers
- 320 people
- Sponsor
- Xijing Hospital
Symptomatic Aortic Stenosis
Optimize PRO Study
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and…
- Trial name
- NCT04091048
- Testing
- Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
- Where
- 60 sites in United States, Australia and 10 more
- Volunteers
- 1,127 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis, Severe
Predictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block
The purpose of the study is implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)
- Trial name
- TAVHIS (NCT05714579)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- France
- Volunteers
- 35 people
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Aortic Valve Stenosis
The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement
The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low…
- Trial name
- 3MTAVR (NCT02287662)
- Testing
- Vancouver 3M Clinical Pathway
- Where
- Canada
- Volunteers
- 411 people
- Sponsor
- BC Centre for Improved Cardiovascular Health
Aortic Stenosis
TAVI Without On-Site Cardiac Surgery in Poland: A Randomized Multicenter Trial Protocol
Aortic stenosis (AS) represents the most prevalent acquired valvular heart disease in European populations, and transcatheter aortic valve implantation (TAVI) has become the dominant treatment modality for patients with…
- Trial name
- NOSCAR-TAVI (NCT07515768)
- Testing
- transcathter aortic valve implantation
- Volunteers
- 404 people
- Sponsor
- Medical University of Warsaw
Removal of Femoral Arterial Sheath in ICU Patients, Complete Hemostasis
Preliminary Exploration of Factors Affecting Complete Hemostasis and Supine Time After Removal of Femoral Arterial Sheath in ICU Patients
Background:Following cardiac catheterization and arterial sheath removal, manual compression is applied until bleeding stops, after which a compression belt is used.
- Conditions
- Removal of Femoral Arterial Sheath in ICU Patients, Complete Hemostasis, Coronary Artery Disease, Percutaneous Coronary Intervention
- Trial name
- NCT07469397
- Testing
- Direct Inspection, medical records browsing
- Where
- Taiwan
- Volunteers
- 157 people
- Sponsor
- National Taiwan University Hospital
Bicuspid-related Aortopathy, Aortic Stenosis
PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation (PROSPERO-TAVI)
Transcatheter aortic valve implantation (TAVI) is being offered to younger patients affected by severe aortic stenosis as an alternative to surgery.
- Trial name
- PROSPERO-TAVI (NCT06248294)
- Testing
- CT follow-up
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- University of Catania
Aortic Stenosis
Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation
The hypothesis behind this study is that there is a proportion of patients considered high or intermediate risk for surgery, but relatively low risk for TAVI, which can be discharged early after the procedure (within the first…
- Trial name
- FAST-TAVI (NCT02404467)
- Testing
- TF TAVI
- Where
- 10 sites in Italy, Netherlands and 1 more
- Volunteers
- 502 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Calcific Aortic Valve Disease, Inflammation
Impact of TAVI on the Gut Microbiota and Its Metabolites
Aortic stenosis is a common heart valve disease in older adults. It occurs when the aortic valve becomes narrowed, making it harder for blood to flow from the heart to the rest of the body.
- Conditions
- Calcific Aortic Valve Disease, Inflammation, Dysbiosis, TAVI
- Trial name
- Swiss-GUT-TAVI (NCT07565077)
- Where
- Switzerland
- Volunteers
- 40 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Transcatheter Aortic Valve Replacement, Conduction Disturbance
Intra-procedural ECG Changes During TAVR
The purpose of this study is to evaluate electrocardiogram (ECG) changes in 100 patients undergoing transcatheter aortic valve replacement (TAVR) to assess new-onset conduction abnormalities, such as atrioventricular nodal block…
- Trial name
- NCT05791344
- Testing
- ECG monitoring
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Cara Medical Ltd
Aortic Stenosis
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
- Trial name
- NCT03735667
- Testing
- ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System
- Where
- 75 sites in United States, Canada
- Volunteers
- 1,948 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Stenosis
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking.
- Trial name
- REVALVE (NCT06557798)
- Testing
- Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication, Surgical explantation and aortic valve replacement, Conservative management
- Where
- 63 sites in Denmark, Finland and 9 more
- Volunteers
- 550 people
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
Left Ventricle Function, Transcatheter Aortic Valve Replacement (TAVR)
Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging
This study aims to enhance and streamline intracardiac 4D Flow magnetic resonance imaging (MRI) processing by increasing automation for the quantitative and systematic assessment of left ventricular (LV) dysfunction.
- Conditions
- Left Ventricle Function, Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Stenosis
- Trial name
- TRANSLATE (NCT07455292)
- Testing
- Cardiac MRI with 4D Flow acquisition and invasive signal routinely collected during transcatheter aortic valve replacement
- Where
- 2 sites in Italy
- Volunteers
- 190 people
- Sponsor
- IRCCS Policlinico S. Donato
Aortic Stenosis
Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive transfemoral…
- Trial name
- NCT02786264
- Testing
- Dexmedetomidine with propofol, Propofol
- Volunteers
- 186 people
- Sponsor
- Yale University